Acellular Dermis in Rotator Cuff Repair

• Sponsor: The Royal Orthopaedic Hospital NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT05458349
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Actual Duration (Months): 94.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears; Rotator Cuff Injuries	Device: acellular dermis	N/A

Detailed Description

Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: It is a Level 1 study, a prospective double blind, randomized controlled trial.It is a Level 1 study, a prospective double blind, randomized controlled trial.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Apr 4, 2013
• Actual Primary Completion Date: Feb 11, 2021
• Actual Study Completion Date: Feb 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dermis group Group will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery	Device: acellular dermis
No Intervention: control group Group will receive standard of care treatment and interventions but the acellular dermal graft will not be used during surgery

Outcome Measures

Primary Outcome Measures

1. rotator cuff healing [12 month post-surgery]

   Rotator cuff healing on MRI

Secondary Outcome Measures

1. Western Ontario Rotator cuff score [12months]

   comparison of scores between groups

2. Constant Murley score [12 months]

   comparison of scores between groups

3. American shoulder and elbow surgeons standardized form [12 months]

   comparison of scores between groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Symptomatic rotator cuff tear that warrants operative intervention.

2. A Tear measuring between 1-5cm at arthroscopy.

3. An arthroscopic rotator cuff repair.

4. Written consent.

Exclusion Criteria:

1. Rotator cuff tears greater than 5cm and less than 1cm

2. Clinical or radiological evidence of osteoarthritis affecting the index side.

3. Patients involved in a Compensation claim related to the shoulder.

4. Inability to attend follow-up for 1 year and to a repeat MRI scan.

5. Previous shoulder surgery or proximal humeral fracture on the index side.

6. Patients that are recruited in a current study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Royal Orthopaedic Hospital NHS Trust	Birmingham		United Kingdom

Sponsors and Collaborators

• The Royal Orthopaedic Hospital NHS Trust

Investigators

• Principal Investigator: Martyn Mr Snow, MD, The Royal Orthopaedic Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Royal Orthopaedic Hospital NHS Trust
• ClinicalTrials.gov Identifier: NCT05458349
• Other Study ID Numbers: ROH11ORTH09
• First Posted: Jul 14, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Royal Orthopaedic Hospital NHS Trust: rotator cuff; shoulder; surgery; acellular dermal graft; acellular dermis; rotator cuff augmentation
• Additional relevant MeSH terms: Rotator Cuff Injuries

Study Results

No Results Posted as of Jul 14, 2022